First Generic FDA Review Time to Drop

Published On: October 8, 2007

Maybe the title should have a question mark after it – will the review time for a first generic drop? FDA plans to do so – it announced the Generic Initiative for Value and Efficiency (GIVE). Basically, the Office of Generic Drugs will try to review within 6 months an application for a first generic that isn’t subject to patent challenges.

FDA has had an informal version of this for the last 2 years. It revised the first in first out policy and allowed a team to work concurrently on several applications of the same generic. We had an ANDA approved in about 11 months, which is 5 months below what the median approval time has been for the last few years. We currently have 2 first ANDA’s in the hopper and we have seen no change in communications that would suggest FDA will review them any quicker. That is, you’d expect that inspections of the API, manufacturer, BE CRO would have to be done faster (first generics almost always get inspected). Has not happened, yet. Maybe it will. The FDA’s objective is laudable – get generic competition quicker to reduce the cost of drugs.

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